Tuesday, December 20, 2016

A new study by Dr. Riccardo Polosa and colleagues, published in the journal Respiratory Research, finds that smokers with chronic obstructive pulmonary disease (COPD) who switch to electronic cigarettes experience an improvement in their symptoms and have fewer COPD exacerbations.

An improvement in respiratory symptoms was observed both in smokers who switched completely to electronic cigarettes and in dual users, although those who switched completely experienced a more substantial improvement.

Although the sample size was small (24 patients in each group), the authors conclude that: "These findings suggest that ECs use may aid smokers with COPD reduce
their cigarette consumption or remain abstinent, which results in marked
improvements in annual exacerbation rate as well as subjective and
objective COPD outcomes."

The Rest of the Story

This study adds to the evidence that electronic cigarettes can play a significant role in achieving harm reduction among smokers who are unable to quit using traditional methods. Why anti-tobacco groups and many health agencies are discouraging smokers from using e-cigarettes to quit smoking is baffling. Ironically, the tobacco companies are encouraging smokers to quit using e-cigarettes, but the health groups apparently don't want to see that happen. There is something very wrong in the modern practice of tobacco control.

Monday, December 19, 2016

Today, I am announcing the finalists for the 2016 Lie of the Year Award. This award will be given to the health agency or organization which has lied most egregiously to the public about smoking and/or vaping in 2016. Feel free to cast your ballot in the comment section. Readers' votes will be taken into consideration in making the final determination. The award consists of a $100 donation to the American Vaping Association and Consumer Advocates for Smoke-Free Alternatives Association ($50 each) made in the name of the winning organization.

The 2016 finalists are:

1. American Thoracic Society

Claim:E-cigarettes are not safer than conventional cigarettes.

The Truth: E-cigarettes are much safer than conventional cigarettes.

Details: In a press release issued in April 2016, the American Thoracic Society stated as follows:

"Frank Leone, MD, chair of the ATS Tobacco Action Committee, believes the
misconception that e-cigarettes are safer than traditional cigarettes
is driving the trend to increased use, which puts children and other
first-time users at risk for significant health problems."

2. University of Louisville

Claim: E-cigarettes are not safer than conventional cigarettes.

The Truth: E-cigarettes are much safer than conventional cigarettes.

Details: In a July 2016 paper published in the journal Current Cardiovascular Risk Reports, Dr. Aruni Bhatnagar of the University of Louisville concluded that:

"The dose-response relationship between smoking and cardiovascular
mortality is non-linear, suggesting that reduction in HPHC
concentrations in e-cigarette aerosols may not result in proportional
harm reduction and decreased HPHC exposure may be offset by increased
use by individuals who believe that e-cigarettes are safer than
conventional cigarettes. Thus, taken together, current evidence does not
entirely support the notion that e-cigarettes are reduced harm products... ."

3. Johns Hopkins All Children's HospitalClaim:Vaping is just as dangerous as smoking.The Truth: Vaping is much safer than smoking.

Details: In an August 2016 web site article, Dr. Rachel Dawkins of the Johns Hopkins All Children's Hospital was quoted as stating:

"Most importantly, parents should talk to their children about the
dangers and harmful side effects of e-cigarettes and others drugs. Parents should also consider vaping just as dangerous as
smoking cigarettes when talking to their teens about the dangers of
tobacco use and smoking."

4. Arizona Department of Health Services

Claim:Vaping is as dangerous as smoking.

The Truth: Vaping is much safer than smoking.

Details: On its web site in October 2016, the director of the Arizona Department of Health Services stated:
"We did research this year with several youth focus groups around the
state and found there is a misconception that using a vape pen is not as
dangerous as a regular cigarette. The truth is there are many of the
same dangerous chemicals in a vape pen that are in a cigarette,
including nicotine which is a highly addictive chemical."

5. Surgeon General of the United States

Claim:Vaping is a form of tobacco use.

The Truth: Vaping is not a form of tobacco use. Electronic cigarettes do not contain any tobacco.

"These products [e-cigarettes]
are now the most commonly used form of
tobacco among youth in the United States, surpassing conventional tobacco
products, including cigarettes, cigars, chewing tobacco, and hookahs."

Details: In a solicitation for donations, the Campaign for Tobacco-Free Kids stated:

"These are just
a few of the [tobacco] industry's latest tricks: ... Using
slick ads, celebrity spokespeople, and sweet flavors like gummy bear and
cotton candy to push e-cigarettes."

7. Alaska Department of Health and Human Services

Claim:Using e-cigarettes is riskier than smoking.

The Truth: Vaping is much safer than smoking.

Details: According to a KTUU Newsarticle in January 2016, Dr. Jay Butler - the state's chief medical officer - stated:

"We do see more kids using e-cigarettes now than smoking, so
e-cigarettes right now are the neatest, shiniest thing and they're kind
of cool so in that sense they do provide a riskier alternative to cigarettes."

8. Centers for Disease Control and Prevention (CDC)

Claim:There was no decline in youth tobacco use between 2011 and 2015.

The Truth: There was a substantial decline in youth tobacco use between 2011 and 2015. Vaping is not a form of tobacco use, so it should not be included in the figure reported by CDC.

Details: In April 2016, the CDC issued a press release stating that there was:

Thursday, December 15, 2016

According to an ABC News story, a Connecticut man was injured when an electronic cigarette exploded in his mouth. The problem, according to the local Deputy Fire Marshal, is that "cheaply made aftermarket batteries can short circuit in milliseconds." The article reports that there have been at least 92 other documented explosions.

There seems to be a simple solution to the problem. The company that manufactured the defective e-cigarette used by this Connecticut man should find a different source of batteries, instead of using the cheap aftermarket batteries that can short circuit in milliseconds.

However, there is just one problem. The FDA deeming regulations do not allow that e-cigarette company, or any of the multiple others whose batteries have exploded, to replace the cheap aftermarket batteries with safer ones. If they did so, it would constitute a new "tobacco product," and could not be placed on the market until the company applied for and received a marketing authorization from the FDA, a process that would take years and millions of dollars. So effectively, the FDA has banned safety improvements such as replacing defective batteries.

Because of this, the FDA deeming regulations represent a clear and present danger to the health of the public. Accordingly, the D.C. District Court should issue an immediate injunction against the enforcement of the new tobacco product application provisions of the regulations, thus allowing companies to make critical safety improvements necessary to protect the health and lives of consumers.

The FDA justifies its regulations based on pure speculation about the hazards of vaping products, yet is taking no action to remedy the one documented adverse health effect of these products: the potential for exploding batteries. Not only is the FDA failing to take action about this problem, but it has made the problem much worse by prohibiting companies from fixing the problem.

In all my years in public health, I cannot think of another public health regulatory action that is so acutely threatening to the public's health.

An alternative to a federal court injunction would be an executive action by the new president directing the FDA to immediately halt enforcement of the pre-market tobacco application requirements of the deeming regulations.

The Rest of the Story

Regardless of how anti-tobacco groups feel about the use of e-cigarettes for harm reduction in tobacco control, all should agree that sensible regulations would not block critical safety improvements to these products. The deeming regulations are nonsensical, and they need to be voided and replaced. This is something I and many others will be working on in the new year.

Ironically, the approach being advocated by anti-tobacco groups to providing safeguards against potential hazards of electronic cigarettes is doing the exact opposite. In contrast, my recommended approach - trashing the new product application process and directly promulgating safety standards - would have taken care of the exploding battery problem years ago.

The rest of the story is that the desire to just get rid of these products has overshadowed the desire to actually regulate the safety of the products and to protect public health and safety. In other words, in the tobacco control movement, ideology has overtaken science.

Wednesday, December 14, 2016

This Monday, the Campaign for Tobacco-Free Kids sent out a solicitation for donations that stated:

"The tobacco industry
spends $9.1 billion a year on marketing in the U.S. alone. That's over $1
million every hour! And much of it is aimed at kids. The industry
needs kids as "replacements" for the nearly half a million Americans
killed by smoking each year, and for those who quit.They know that
90% of smokers start as teens or earlier. That's why their marketing is geared
toward youth. But they're
not just selling your dad's cigarettes or your grandpa's cigars anymore. The
industry is introducing new products to lure another generation of kids into
addiction. And they're going to extraordinary lengths to make these products
cheap, "cool," and highly visible."

This certainly sounds like a show stopper and an excellent reason for people to donate to the Campaign. The tobacco industry is targeting kids with gummy bear and cotton candy cigarettes. Sounds pernicious. Who wouldn't want to help the Campaign stop the tobacco industry from preying on kids like this. I mean, seriously? Gummy bear and cotton candy e-cigarettes?

The Rest of the Story

While effective, there's just one problem with the Campaign for Tobacco-Free Kids' appeal:

It's not true!

Not a single one of the tobacco companies is producing gummy bear or cotton candy e-cigarettes.

Thus, not a single one of the tobacco companies are producing gummy bear or cotton candy e-cigarettes.

The cotton candy and gummy bear flavors of e-liquids are being produced by independent companies that have nothing to do with Big Tobacco. However, that apparently does not make a good enough story to solicit donations. So instead of just telling the truth, the Campaign for Tobacco-Free Kids decided to lie and tell people that Big Tobacco is the culprit for marketing these flavors.

When I used to work for the American Heart Association, the American Lung Association, and other anti-smoking organizations, we were always very careful to be accurate in our communications, especially when we were accusing the tobacco companies of inappropriate behavior. We carefully documented all allegations that we were making, so as to be sure that we were being truthful and avoiding making potentially defamatory accusations.

Today, it appears that not only caution, but honesty itself is thrown to the wind.

So if the Campaign for Tobacco-Free Kids is going to lie to the public, then why not make the solicitation even more appealing? If the truth doesn't matter, then why not just accuse the tobacco companies of lacing e-cigarettes with cyanide? That would make a great appeal. But if you think the reason the Campaign is not making such a claim is that it is inaccurate, you would be wrong. We've already established that making truthful claims is apparently not part of the criteria for the Campaign's public statements.

The rest of the story is that the Campaign for Tobacco-Free Kids is lying for money. They are dishonestly claiming that tobacco companies are marketing gummy bear and cotton candy e-cigarettes in order to create a more shocking appeal for donations.

I do not understand why there seems to be such a need for
health agencies and anti-tobacco groups to lie about electronic cigarettes. And
we are not just talking about mild degrees of deception. We are talking here
about factual misrepresentations of the truth. I don’t understand why telling
the truth is not good enough. Honesty is part of the public health code of
conduct. Moreover, since we have spent years attacking the tobacco companies
for their history of lies and deceit, it seems that we should be beyond
reproach in the honesty of our own public communications. I understand the need
to solicit donations, but it seems to me that an honest appeal would have been
equally effective.

I have certainly issued my fair share of attacks on the
tobacco industry, as much as the next guy. I testified against the tobacco
companies at least 11 times, including 5 times in the Engle case alone. But I
was always careful to provide documentation of my assertions about the
industry’s misconduct. I don’t think the fact that the industry has acted
irresponsibly in the past gives us carte blanche to say anything we want about
them now.

I think the Campaign for Tobacco-Free Kids needs to produce
the documentation that supports its accusation that the tobacco industry is
marketing gummy bear and cotton candy e-cigarettes, or else issue a retraction
and an apology to their constituents.

Tuesday, December 13, 2016

The claims of anti-tobacco groups and health agencies -- including the Surgeon General's Office -- that youth e-cigarette experimentation leads to smoking have been essentially destroyed after this morning's release of results from the 2016 Monitoring the Future Survey.

The 2016 survey finds that from 2015 to 2016, current cigarette smoking among 8th and 10th grade students dropped by the greatest amount in history. For 8th graders, current smoking dropped from 3.6% to 2.6%. Among 10th graders, smoking dropped from 6.3% to 4.9%.

Smoking among 12th graders also declined, although not as sharply as from 2013 to 2014, dropping from 11.4% to 10.5%.

From 2013 to 2016, a period during which e-cigarette use among youth skyrocketed, current smoking among 12th graders dropped from 16.3% to 10.5%. Among 10th graders, current smoking during this period dropped from 9.1% to 4.9%.

The survey also found that rates of past 30-day vaping itself among 10th and 12th graders dropped for the second consecutive year, falling from 16.2% to 12.5% among 12th graders and from 14.0% to 11.0% among 10th graders.

The Rest of the Story

At this point, it is clear that whatever the risks of youth vaping may be, one of them is not the risk of progressing to smoking. If this hypothesis were true, we would simply not be seeing the historic declines in youth smoking that are occurring. Quite clearly, smoking continues to be de-normalized, not re-normalized as anti-tobacco groups and many health agencies have claimed. It appears that a culture of vaping is largely replacing a culture of smoking.

If anything, it appears that the advent of e-cigarettes has accelerated the de-normalization of smoking by largely replacing it. Increases in vaping are mirrored by corresponding declines in youth smoking. Vaping appears not to be making smoking more cool, as claimed by the Surgeon General, the CDC, and anti-tobacco groups, but to be making smoking less cool.

It also appears that there has been a plateau and now a decline in the rising fad of youth vaping, which should help ease the concerns of anti-tobacco groups that an entire generation of kids is going to be addicted to nicotine.

These data are cause for celebration. They show that smoking continues to be less cool among teenagers and suggest that the new vaping culture has contributed further to the de-normalization of smoking. Given the high potential of smoking during adolescence to lead to a lifetime of cigarette addiction and its resulting disease and premature death, it appears that the phenomenon of youth e-cigarette experimentation has been a net positive for the public's health, or at very least neutral. This does not mean that youth vaping should be promoted, but it does mean that the claims of health agencies, including the Surgeon General's office, are simply not standing up to scientific scrutiny.

If the science matters in tobacco control - which apparently it doesn't - this should put an end to the Surgeon General, the CDC, and others claiming that youth experimentation with e-cigarettes will lead to a progression to smoking and to a re-normalization of smoking among youth. What we need is not a further campaign of lies and deception about how tobacco use "in any form," including e-cigarettes, is horrific, but a truthful campaign that acknowledges different levels of risk of nicotine-containing products, informs youth that e-cigarettes do not contain tobacco and are therefore not a form of tobacco use, and explains that most e-cigarettes do contain nicotine and may also expose them to other chemicals which could be harmful with long-term use.

It is interesting that the Surgeon General released his report just prior to the release of these new data. Perhaps he realized that once these data came out, his "story" about the scourge of e-cigarettes would be destroyed, so he wanted to get it in so it could have the maximum media impact. Even if it is purely a coincidence, it is going to be difficult to undo the damage caused by the Surgeon General's report.

According to the Arizona Department of Health Services, vaping is just as dangerous as smoking. The state health department has initiated a campaign entitled "Vape is a Lie" to teach kids about the dangers of vaping and nicotine use. The director of the state agency describes the primary purpose of the campaign as follows:

"We did research this year with several youth focus groups around the
state and found there is a misconception that using a vape pen is not as
dangerous as a regular cigarette. The truth is there are many of the
same dangerous chemicals in a vape pen that are in a cigarette,
including nicotine which is a highly addictive chemical."

According to the Department: "Our goal with this new campaign is to give youth the truth about the potential dangers of using e-cigarettes."

The Rest of the Story

Ironically, the rest of the story is that it is the Arizona Department of Health Services which is telling the greatest lie about vaping. It is simply not true that using a vape pen is as dangerous as smoking a real cigarette. In fact, vaping is much safer than smoking. There is abundant research which demonstrates this. But it is also common sense, as electronic cigarettes contain no tobacco and do not involve combustion. How could they be as dangerous as tobacco cigarettes, which we know kill more than 400,000 Americans each year? There is no legitimate scientific dispute over the fact that vaping is much safer than smoking.

If the goal of the new campaign is "to give youth the truth," then it is failing miserably. Rather than providing youth with the truth, the campaign is blatantly lying to kids. Not only is it giving them false information about the relative risks of vaping vs. smoking, but it is undermining decades of public education about the severe hazards of smoking.

Why is there a need for the Arizona Department of Health Services to lie? Why isn't the truth enough? Not only does this campaign run afoul of the public health code of conduct, of which honesty is a key principle, but the campaign also insults the intelligence of youth. It assumes that kids are so stupid that you have to lie to them. What kind of message does this send, especially to parents? Apparently, the Arizona Department of Health Services thinks that parents should lie to their kids about the hazards of vaping. This runs counter to the basic principles of public health and to the principles of risk communication.

Tim Mechling of Mt Baker Vapor breaks down the dishonesty of the Vape is a Lie campaign in a post aptly entitled "'Vape is a Lie' is a Lie."

Sunday, December 11, 2016

A survey conducted by the Pew Foundation this past weekend found that self-reported rates of youth vaping have dropped sharply following Thursday's release of the Surgeon General's report on e-cigarette use, which, after a 263-page review of the scientific evidence, warned that vaping is "not harmless" and that e-cigarette aerosol is not "just water vapor."

Foundation president Robert J. Pew said that although the survey results are subject to a margin of error, "the decline is so sharp that even with the maximum amount of error, the drop in vaping is significant." While Pew acknowledged that the decline cannot "definitively be attributed to the report," the timing of the findings is uncanny and "it is difficult to believe that anything else could explain such a sharp decline."

Pew also noted that it is plausible that the report would have immediately affected so many youth, because "we know how sensitive kids are to finding out that a behavior is not harmless. They immediately stop doing it. We saw exactly the same thing after the Surgeon General released his 2015 report on alcohol, in which he concluded that alcoholic beverages are not just "pure water." Youth drinking rates plummeted within weeks of that report's release.

The Surgeon General's office also defended the plausibility of the quick decline in vaping, reminding reporters of the immediate and dramatic increase in calls to the smoking quitline following the release of the landmark 1964 Surgeon General's report on smoking, which concluded that contrary to public opinion, smoking is "not harmless" and inhaling tobacco smoke is not the same as "breathing in clean air."

Health advocates across the nation have demanded that federal, state, and local governments take drastic action to protect youth from what the American Lung Association has called "a scourge of devastating impacts from exposure to non-harmless chemicals." The American Heart Association similarly warned of what it called "an impending epidemic of non-harmless recreational behavior among our nation's youth."

An American Lung Association spokesperson explained that: "Youth should not inhale anything other than pure, clean air. And they should only engage in behaviors which have been determined by the federal government to be harmless."

The Lung Association spokesperson cited several recent federal actions, such as the elimination of high school football in 2013 after studies showing that repeatedly getting hit in the head with a hard helmet worn by a 215-pound lineman is not harmless and the ban on resistance training programs in high school gym classes because it has been shown to cause an acute increase in the number of epithelial progenitor cells, which Dr. Stan Glantz has said "are markers of damage to the lining of arteries (called the vascular
endothelium)." Glantz added that: "Damage to the endothelium is linked to immediate
increases of the risk of a heart attack in people at risk of heart
attacks and also contributes to the long-term development of
atherosclerosis (buildup of blockages of arteries in the heart) and
peripheral vascular disease (blockage of other arteries)."

A review of interventions to prevent risk-taking youth behavior published in Annual Reviews of Public Health in 2014 reported that educational campaigns which inform kids that there are possibly some risks associated with health behaviors are "highly effective" in preventing those risk-taking behaviors. The article cited the steep decline in youth marijuana use following the Surgeon General's 2015 conclusion that "the inhalation of smoke from burning leaves containing a psychoactive substance may not be risk-free."

When asked why the report could say nothing worse about vaping than that it is merely "not harmless," the Surgeon General's office explained that: "there actually have been no studies that have documented any actual harms to youth from vaping. It would be pure conjecture to conclude from the present evidence that vaping carries significant harms, and that is not something a Surgeon General's report would ever do."

Despite popular misconceptions, the tobacco companies did not try to impede the Surgeon General's report on smoking in 1964. Joseph F. Cullman III, Philip Morris president at the time, is widely reported to have joked in internal memos: "Johnny is alive and well. If all the Surgeon General can say about smoking is that it is 'not harmless,' we are in a position to thrive. Until something safer comes along - like a non-tobacco cigarette that delivers nicotine without combustion - the market for combustible tobacco products will remain strong and active."

Several high school youth interviewed over the weekend by CNN confirmed that as soon as their classmates learned that vaping was not harmless, they immediately stopped. "Instead of blowing vape rings at parties, the cool thing now is to drink pure mountain spring water," said 16-year-old Heather Walters of Oak Spring, Illinois.

The National Association for the Preservation of Puritan Practices (NAPPP) released a statement praising the Surgeon General's report on vaping: "It's great to see that the Surgeon General of the United States is so deeply committed to preventing even the most minor of risks among youth and that he is willing to hysterically cast as a dire threat any behavior that might convey any risk. It's also great to see that he understands the importance of not differentiating between the levels of different risks. To be pure, moral, and safe, you have to disavow all risky practices, not just the most strikingly dangerous ones. And if you think that switching from an extremely hazardous behavior to one that is just 'not harmless' will save you from eternal damnation, you've got something coming to you."

The Department of Health and Human Services' campaign to condemn e-cigarettes follows a long public health tradition of banning or seeking to prevent any behavior that merely reduces harm. According to a deputy secretary, the demonization of e-cigarettes is consistent with the Department's long-standing opposition to sex education, methadone maintenance programs, needle exchange programs, distribution of naloxone to emergency responders and law enforcement officers, and promotion of "low-calorie" rather than "no-calorie" diets.

ADDENDUM: This is a parody. It was written to highlight the absurdity of the Surgeon General's report and the approach it takes to tobacco control. I thought it was obvious but a number of people have been asking to see the survey results. Stay tuned, however, as there should be some actual survey results out later this week.

Friday, December 09, 2016

A major tobacco company today announced a new, national advertising campaign that is based on the primary message that since the Surgeon General has declared that any form of tobacco use is harmful, people might as well smoke since it provides the best "nicotine hit" of any tobacco product currently on the market. The campaign will roll out over the next six months, with print media ads first appearing in February 2017.

Unlike previous tobacco company ad campaigns, which have relied upon the industry's own claims, this campaign is based entirely on the statements of the Surgeon General, the FDA, the CDC, and other public health groups. The company's president and chief executive officer stated in a press release announcing the campaign: "We realize that in 2016, we don't enjoy a great deal of public trust. So we're saying 'don't take our word for it, listen to what public health authorities like the Surgeon General have to say.'"

While the actual ad executions to be used in the campaign have yet to be developed, several mock-ups of sample ads showed that the industry's main message is that people should not be deceived into thinking that by switching from smoking to another form of tobacco use they will eliminate their disease risk. One mock-up emphasizes that even if smokers switch to tobacco-free e-cigarettes, they are still at risk of tobacco-related disease. An excerpt from the text of that ad reads:

flavorants such as diacetyl, a chemical linked to serious lung disease

volatile organic compounds

heavy metals, such as nickel, tin, and lead."

The second mock-up also quoted from the Surgeon General's report:

"While these products are novel, we know they contain harmful ingredients that are dangerous. Tobacco use among youth and young adults in any form, including e-cigarettes, is not safe."

The tobacco company's director of communications emphasized that: "We agree that all smokers should try to quit. All we are saying is that if someone is unable to quit and makes an informed decision to use a tobacco product, they should understand that all forms of tobacco are unsafe. So whether they are using smokeless tobacco, snus, cigars, e-cigarettes, or the nicotine patch, all tobacco and nicotine products are dangerous."

The same tobacco company also announced that it will initiate a $15 million national campaign to educate youth about the hazards of all nicotine and tobacco use. "Youth need to understand that vaping is not safe. We want all youth to be aware that it doesn't matter whether you smoke, vape, light a cigar, or use a nicotine inhaler. It's all the same. They're all dangerous."

Research has shown that although nicotine is present in cigarettes, cigars, smokeless tobacco, and many e-cigarettes, none of these products delivers nicotine as efficiently as the cigarette, which has been perfected over decades to deliver nicotine quickly into the bloodstream and to the brain in a manner which creates a nicotine "hit" that the user experiences to a much greater degree than with other forms of tobacco. The tobacco company's public relations director stated that: "We are absolutely not encouraging anyone to smoke. We just want them to be aware of the facts as laid out clearly by the Surgeon General. All existing alternatives to the cigarette are hazardous. Don't fool yourself by thinking that if you switch from smoking to say, vaping, you are safe. Just be aware that if you make a decision to use nicotine, smoking is clearly the only activity where you will feel the nicotine hit strongly."

In response to this morning's announcement, several anti-tobacco groups were angry and accused the industry of perpetrating a hoax. The newly-named "Campaign for Nicotine-Free Kids" stated in a press release that: "We don't buy the argument that the industry is just trying to educate youth about the dangers of all tobacco products. We think that by emphasizing that all tobacco use is harmful, by lumping in e-cigarettes with real tobacco cigarettes, the industry wants youth to think that smoking does not carry particularly severe health risks. Putting cigarettes in the same category as vaping products and nicotine patches is deceptive and dishonest. The tobacco companies say they have changed, but this demonstrates that the industry is still living in the 20th century."

The Surgeon General's office, responding this morning to criticism of its characterization of electronic cigarettes as a "form of tobacco use," explained its reasoning:

"Whether e-cigarettes contain tobacco or not isn't the issue. The key point is that most e-cigarettes contain nicotine, a chemical that is a central component of tobacco. Any consumed product that contains nicotine represents a form of tobacco use. Given the known effects of nicotine on adolescent brain development, youth should not be using any tobacco product."

The Associated Press compiled a list of products that meet the Surgeon General's definition of a form of tobacco use. They include:

cigarettes;

smokeless tobacco;

snus;

cigarillos;

cigars;

bidis;

hookah;

electronic cigarettes;

other vaping products;

nicotine patch;

nicotine gum;

nicotine inhaler;

nicotine lozenges;

potatoes;

tomatoes;

eggplant;

cauliflower;

peppers;

green tea; and

black tea.

While the Surgeon General claimed yesterday that electronic cigarettes are now the predominant form of tobacco use among youth, the Associated Press conducted a fact-checking analysis which revealed that the Surgeon General's statement is not accurate. According to statistics compiled by the AP, tomatoes are actually the predominant form of tobacco use among youth.

The North Carolina Tomato Growers Association reacted angrily to the Associated Press article. A spokesperson for the NCTGA said: "This is really disingenuous. I mean, calling us a form of tobacco use simply because we contain nicotine is ludicrous. Look, the bottom line is we don't contain any tobacco. North Carolina tomatoes are not even grown in the same areas of the state as tobacco. Lumping our products in with cigarettes, which kill hundreds of thousands of Americans each year, is an injustice."

Although a spokesperson for the Long Island Cauliflower Association did not immediately respond, the Association posted on its web site the following statement: "We challenge anyone who declares that cauliflower impairs adolescent brain development to show us the evidence. Yes, cauliflower contains nicotine. We admit that. But it doesn't make us a form of tobacco use. We will take any steps necessary, including legal action, to have our products taken off the Associated Press list."

Monday, December 05, 2016

One of the things I always teach my public health students about research is that when you conduct any type of longitudinal or time-series data analysis, you should always start by graphing the outcome variable over time and visually inspecting the data. A perfect demonstration of what might happen if you fail to do this was published last week in the journal Tobacco Control.

Briefly, as I reported last week: A new study published online ahead of print in the journal Tobacco Control purported to demonstrate that a smoke-free bar and restaurant law
implemented in São Paulo, Brazil in August 2009 resulted in a 11.9%
decline in the heart attack death rate for the first 17 months after the
law was in effect (through December 2010).
The paper used a time-series analysis to compare the monthly rate of
heart attack deaths prior to the smoking ban to the rate after the ban
was implemented. The baseline period was January 2005 through July 2009.
The implementation period was August 2009 through December 2010. Thus,
the researchers had data for approximately 5 1/2 years before the ban
and for 17 months after the ban.
The paper concluded: "In this study, a monthly decrease of almost 12%
was observed in mortality rate for myocardial infarction in the first 17
months after the enactment of the comprehensive smoking ban law in São
Paulo city."

The problem is that if you take the time to look at the actual data, you find that there was actually a striking increase in heart attack deaths in the year following the smoking ban:

Christopher Snowdon over at Velvet Glove, Iron Fist has graphed out the monthly data, and the picture looks the same:

You can see that there was a seasonal decline in heart attack deaths late in 2009, but a striking increase in heart attack deaths in 2010 that was sustained throughout the year. In fact, the number of heart attack deaths for each month in 2010 was higher than the number of heart attack deaths during the same month in any of the previous years in the study period!

As Snowdon explains the actual data: "Before the ban, the number of deaths hardly ever exceeded 600 per month
and was often below 500. Within a few months of the ban, there were
never fewer than 700 deaths per month."

In my post last week, I struggled to understand how an error like this could have escaped the attention of the investigators, the reviewers, and the journal and speculated that: "It appears that either nobody looked at the actual data or that they
looked but ignored it. Either way, this demonstrates a severe bias on
the part of the investigators, reviewers, and editorial team. Had the
study found no effect of a smoking ban, you can rest assured that
everyone would have scoured over the paper for hours, trying to find
some explanation for why the results came out "wrong." But here, since
the results were "right" (that is, favorable), it appears that there was
no desire to sincerely "review" the paper."

However, in the back of my mind, I wondered whether this was all just a mistake. Perhaps there was just a typographical error and the data presented in Table 2 were mistaken. Perhaps the 2010 data presented were an anomaly and were not transcribed correctly from the original manuscript to the typeset paper. I was actually "hoping" that this would be the case and that I would have to write a retraction and correction.

The Rest of the Story

It was not to be so. The lead author of the paper confirmed that the data in Table 2 are correct. In other words, the statistical analysis miraculously turned a clear and rather striking increase in heart attack deaths into an 11.7% decline: a true miracle. Instead of blindly reporting these results, this inconsistency should have instead led the investigators to figure out what went wrong, and it should have led the reviewers and journal editors to question the analysis and interpretation of the data.

This might seem like a rather obvious epidemiological point to make but you cannot have a decline in the heart attack death rate if the heart attack death rate goes up.

Before anyone suggests as a possible explanation that perhaps the population rose drastically in 2010, thus making the high number of deaths in 2010 translate into lower death rates, let me emphasize that explanation is impossible. The paper did not use the actual annual populations but simply used a geometric progression to interpolate the populations based on censuses conducted in 2000 and 2010. Thus, the rate of population growth throughout the study period was constant, by definition.

It also needs to be remembered that even if the paper had found an actual decline in heart attack deaths in 2010,
this would not justify the conclusion that the smoking ban caused a
decrease in heart attacks. Another critical and fatal methodological flaw of
this paper is that there is no comparison group. It is very possible
that heart attack death rates were declining during the study period
anyway, even in the absence of smoking bans. We actually know this to be
the case from abundant international data. To conclude that the smoking
ban had an effect on heart attacks, one would need to first control for
secular trends in heart attack mortality that were occurring anyway,
independent of the smoking ban. The paper could easily have done this by
including some comparison group -- such as a nearby city, the county,
the state, or the country. But there needs to be some control for
secular trends.

The rest of the story is that we have here another example of the severe bias in modern-day tobacco control research. The zealotry has reached such a level that you can report frivolous findings that are not even consistent with visual observation of the data and still publish your paper without questioning from peer reviewers or journal editors, as long as the findings you are reporting are "favorable" to the cause. You can rest assured that had the paper found "unfavorable" findings, they would have received critical scrutiny.

For a similar take on this study, see Christopher Snowdon's commentary.

Wednesday, November 30, 2016

In a letter written last week to the FDA, Senator Ron Johnson (R-WI) called on the FDA to halt implementation of the e-cigarette deeming regulations pending the change in administration coming this January.

Senator Johnson wrote: "The incoming administration and the 115th Congress will likely re-examine and unwind burdensome regulations imposed by the Obama Administration. The U.S. Food and Drug Administration's (FDA) deeming regulations of e-cigarettes is a primary example of a rule that could eliminate an entire nascent industry. Accordingly, given the substantial likelihood that this burdensome rule will be undone, I urge the FDA to cease implementation of its deeming regulation to spare the growing e-cigarette industry unnecessary and avoidable compliance costs that it currently faces."The Rest of the Story

I do not generally agree with Republican calls for a loosening of public health regulations, but in this case, I wholeheartedly agree with Senator Johnson. The FDA e-cigarette deeming regulations are unduly burdensome and will result in the decimation of the e-cigarette industry, putting thousands of small vape shops and companies out of business and protecting cigarettes from competition from a much safer product. Moreover, the deeming regulations violate the free speech rights of e-cigarette companies, prohibit the companies from taking steps to improve the safety of their product, and force companies to lie to consumers about the primary benefits of their products. This is a public health mess, and it does need to be unraveled.

The good news is that it appears that the new administration, or at least the new Congress, are planning to conduct a serious re-examination of the regulation of electronic cigarettes. Therefore, it is possible that we may be able to come out of this with more than just the Bishop-Cole "emergency" measure that would salvage the industry. Instead, it is possible that we can achieve a more sensible regulatory framework for e-cigarettes, one that treats these products completely differently from tobacco cigarettes, allows smoking cessation and modified risk claims to be made, eliminates the burdensome pre-market applications, and instead, sets safety standards for these products to ensure uniform safety and quality control, thus maximizing the benefits of vaping products while minimizing the risks.

This presents an important opportunity for vapers to make their voices heard. While CDC director Dr. Thomas Frieden views vapers only as "anecdotes," their collective experiences truly represent data that can help inform policy. Vapers need to share their experiences with members of Congress, especially members of the Senate Homeland Security and Government Affairs Committee, so that they will be able to separate out the fact of their experiences from the fiction that so many anti-smoking groups and health agencies have been spreading.

Tuesday, November 29, 2016

A new study published online ahead of print in the journal Tobacco Control purports to demonstrate that a smoke-free bar and restaurant law implemented in São Paulo, Brazil in August 2009 resulted in a 11.9% decline in the heart attack death rate for the first 17 months after the law was in effect (through December 2010).

The paper used a time-series analysis to compare the monthly rate of heart attack deaths prior to the smoking ban to the rate after the ban was implemented. The baseline period was January 2005 through July 2009. The implementation period was August 2009 through December 2010. Thus, the researchers had data for approximately 5 1/2 years before the ban and for 17 months after the ban.

The paper concluded: "In this study, a monthly decrease of almost 12% was observed in mortality rate for myocardial infarction in the first 17 months after the enactment of the comprehensive smoking ban law in São Paulo city."

The methods used in the study are quite complex and are summarized as follows: "We performed a time-series study of monthly rates of mortality and
hospital admissions for acute myocardial infarction from
January 2005 to December 2010. The
data were derived from DATASUS, the primary public health information
system available
in Brazil and from Mortality
Information System (SIM). Adjustments and analyses were performed using
the Autoregressive Integrated
Moving Average with exogenous
variables (ARIMAX) method modelled by environmental variables and
atmospheric pollutants to
evaluate the effect of smoking ban
law in mortality and hospital admission rate. We also used Interrupted
Time Series Analysis
(ITSA) to make a comparison between
the period pre and post smoking ban law."

In simple terms, the investigators compared the trend in heart attack deaths in São Paulo before the smoking ban to the trend in heart attack deaths in São Paulo after the smoking ban. They concluded that there was an 11.7% drop in the heart attack death rate in the 17 months following the implementation of the smoking ban.

The investigators attributed the observed decline in heart attack deaths to a reduction in secondhand smoke exposure, citing evidence that just 30 minutes of exposure to secondhand smoke can cause a heart attack.

The Rest of the Story

To demonstrate the blatant bias in the reporting of the study results, simply take a look yourself at the actual data from the study. Below, I have plotted the data from Table 2 (Monthly number of deaths for myocardial infarction, city of São Paulo, Brazil, January 2005 to December 2010), but I have added the monthly numbers to yield annual figures, which smooths the data making it much easier to inspect visually.

The smoking ban went into effect in August 2009. You can easily see from the figure that in 2010, there was a striking increase in the number of heart attack deaths, which reached an all-time high for the study period.

Somehow, it appears that all this fancy modeling yielded a completely spurious result. This is why I teach my students to always start out by looking at the actual data. When you put the data into a fancy statistical model, strange things can happen. You always need to make sure that the results of a statistical model are consistent with what you are observing visually when you look at the data. If there is a major inconsistency, as in this case, then you must suspect that something is wrong: namely, that the statistical technique is for some reason not modeling the data correctly. It is also possible that the data are wrong. But clearly, something is wrong here.

Here, an examination of the actual data reveals that there is absolutely no basis to conclude that the smoking ban resulted in an 11.7% decline in heart attack deaths.

But why did nobody see this? It's difficult to believe that the authors didn't see it, the reviewers didn't see it, and the journal editorial team didn't see it. This should in fact be the first thing that everybody looks at. Even if you just look at the data in Table 2 without plotting it out, it is immediately apparent that there was a striking increase in heart attack deaths in 2010, wiping out the possibility that the smoking ban led to a large and sustained decline in heart attack deaths through 2010.

It appears that either nobody looked at the actual data or that they looked but ignored it. Either way, this demonstrates a severe bias on the part of the investigators, reviewers, and editorial team. Had the study found no effect of a smoking ban, you can rest assured that everyone would have scoured over the paper for hours, trying to find some explanation for why the results came out "wrong." But here, since the results were "right" (that is, favorable), it appears that there was no desire to sincerely "review" the paper.

Finally, it is critical to mention that even if the paper had found a decline in heart attack deaths in 2010, this would not justify the conclusion that the smoking ban caused a decrease in heart attacks. The critical and fatal methodological flaw of this paper is that there is no comparison group. It is very possible that heart attack death rates were declining during the study period anyway, even in the absence of smoking bans. We actually know this to be the case from abundant international data. To conclude that the smoking ban had an effect on heart attacks, one would need to first control for secular trends in heart attack mortality that were occurring anyway, independent of the smoking ban. The paper could easily have done this by including some comparison group -- such as a nearby city, the county, the state, or the country. But there needs to be some control for secular trends.

Thus, even if this paper had convincingly demonstrated that there was a decline in heart attacks in São Paulo after the smoking ban, it would not have been valid to conclude that this was a causal effect. Without a comparison group, this study is as good as worthless.

When the tobacco industry used to put out studies like this to show that smoking bans cause massive losses of revenue for restaurants, we attacked them for conducting time series analyses without using an appropriate control group. Now it appears that we are doing the same thing ourselves. This certainly has the appearance of a severe bias: results that are "favorable" are correct and the methodology is automatically valid and those which are "unfavorable" are incorrect and the methodology must be attacked.

Perhaps one of my great frustrations of 2016 is the way in which science has largely disappeared from the public policy agenda. Decisions are being made almost completely on political grounds. It is a bad enough state of affairs that we in public health don't need to contribute to it. Even though we are working for worthwhile causes, we cannot let loose our insistence on rigorous science. Once we do that, then we're really sinking to the level of our opponents.

Finally, I should make it clear that any failure of this study to detect an immediate decline in heart attack deaths does not affect my support for smoke-free bar and restaurant laws. It's just that in promoting such laws, I believe we need to rely upon solid scientific data, not hocus pocus that comes out of some complex statistical model that no one really understands and which ends up completely misrepresenting the actual data -- data that one can see with one's own eyes.

Monday, November 28, 2016

The misleading information being spread to the public by vaping opponents, including prominent health agencies like federal, state, and local health departments, has become out of control. It threatens to do immense public health damage by protecting cigarette sales at the expense of a much safer alternative - electronic cigarettes - and at the same time it also threatens the reputation of public health agencies.

Today, I highlight four examples of misinformation about electronic cigarettes from vaping opponents, representing four levels of health groups: international, national, state, and local.

International

World Health Organization:

Vaping does not help people stop smoking

The World Health Organization (WHO) is waging an all-out war on electronic cigarettes, which is ironically helping to protect real cigarettes from what otherwise could have been immense competition from a much safer product. The WHO could hardly be doing the cigarette companies around the world any greater favor. Recently, a WHO report prepared for the Conference of the Parties (COP-7) meeting concluded that vaping does not help people stop smoking. Furthermore, the head of the convention secretariat made clear her opinion that electronic cigarettes "should not be promoted widely."

According to an article in The Guardian, Anna Gilmore, professor of public health at the University of Bath and the UK Centre for Tobacco Control Studies, stated: "The tobacco industry uses e-cigarettes to claim it is committed to
harm reduction, but meanwhile it continues to engage in harm
maximisation by spending millions to promote tobacco and oppose any
policy that would reduce its use."

How ironic that Professor Gilmore is attacking the tobacco industry for opposing "any policy that would reduce" tobacco use, while at the very same time (and in the same sentence) she is vigorously opposing one of the most promising strategies ever for reducing tobacco use (vaping). In the same sentence, she condemns the tobacco industry for not being "committed to harm reduction," yet expresses her own opposition to harm reduction.

The rest of the story is that it is not the tobacco industry that is holding up the use of harm reduction as a widespread tobacco control strategy. In fact, the tobacco companies are largely supporting a harm reduction approach, and they are vigorously promoting vaping products. On the other hand, it is the tobacco control community and health agencies like the WHO that truly are holding up harm reduction through their opposition to promoting vaping as a much safer alternative to smoking.

National

Centers for Disease Control and Prevention:

Reductions in the amount of cigarettes smoked daily by smokers represent great progress, but not among vapers

The director of CDC - Dr. Tom Frieden - was quoted recently as stating: "The pack-a-day smoker has become more and more rare. What we've seen is a shift from heavier smokers to lighter smokers.
We're seeing really good progress."

What Dr. Frieden failed to reveal was that one major reason for recent declines in cigarette consumption is that millions of smokers are switching - in whole or in part - to vaping. And even those who switch only in part (so-called "dual users") are greatly improving their health if they cut down substantially on the amount they smoke. They are also reducing their level of smoking addiction which makes it easier for them to quit in the future. There is no question that the widespread use of electronic cigarettes, while strongly opposed by Dr. Frieden and the CDC - is contributing to declines in the amount smoked daily by smokers. Thus, the CDC is hindering the very "progress" that it claims to support.

State

The Ohio State University Comprehensive Cancer Center

We have no idea whether vaping is any safer than smoking

According to a statement from the deputy director of the Ohio State University Comprehensive Cancer Center, we have no idea whether vaping is any safer than smoking: "There is minimal data available regarding the direct health effects of
e-cig use or vaping, but these products have gained rapid popularity
among existing smokers and non-smokers alike, including young adults. We are concerned that people assume these products have
fewer negative health effects as compared with cigarettes and other
tobacco products. The reality is that they are still a tobacco product
and people are still inhaling potentially harmful chemicals. They should
not be considered a 'safer' option until science has the opportunity to
catch up with the consumer market."

To further emphasize his statement that we have no idea whether smoking is any more hazardous than vaping, the deputy director said: "We have no idea where in the spectrum these are, in terms of safety. Are they like cigarettes, or nothing like cigarettes?"

It is disturbing to me that a comprehensive cancer center that every day sees the devastation to people's health and lives caused by smoking is unable to conclude that smoking is any more hazardous than vaping, despite scores of studies demonstrating the relative safety of vaping compared to smoking. Are you serious? Anyone who takes an even cursory look at the scientific evidence will tell you that there is no question that vaping is much safer than smoking. Even Stan Glantz - a vaping opponent - acknowledges that there is no question vaping is safer than smoking.

Local

Knox County Health Department (Knoxville, Tennessee)

Vaping is not healthier than smoking

According to a "fact sheet" from the Knox County Health Department: "Vaping devices are often marketed as the “smarter” or “healthier” alternative to smoking. The literature has yet to prove this claim. ... There is no proof that they are “safer” or “healthier” than smoking, or if they pose different or additional risk."

A public health department should not be telling the public in 2016 that there is no proof that smoking is any more hazardous than vaping. Even the tobacco companies themselves aren't saying this. In fact, the tobacco companies are telling the truth and acknowledging that vaping is a safer alternative to smoking. It seems only to be health agencies that are still denying the science on vaping and smoking.

The Rest of the Story

For years we attacked the tobacco companies for misleading the public about the health effects of smoking. Now we are doing exactly the same thing. But I don't believe that it is unacceptable for the tobacco industry to mislead people while it's acceptable for us to do it. We need to be beyond reproach in our dissemination of information, and especially recommendations, to the public. A fear that vaping might spread does not justify deception of the public. Honesty is the best policy. In a political climate that is full of dishonesty, I think the last place we need more of it is in public health.

About Me

Dr. Siegel is a Professor in the Department of Community Health Sciences, Boston University School of Public Health. He has 32 years of experience in the field of tobacco control. He previously spent two years working at the Office on Smoking and Health at CDC, where he conducted research on secondhand smoke and cigarette advertising. He has published nearly 70 papers related to tobacco. He testified in the landmark Engle lawsuit against the tobacco companies, which resulted in an unprecedented $145 billion verdict against the industry. He teaches social and behavioral sciences, mass communication and public health, and public health advocacy in the Masters of Public Health program.